Cleared Traditional

K881284 - COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE

K881284 is an FDA 510(k) clearance for COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY..., manufactured by Nathaniel Gould Diagnostics, Inc.. The device is a Class 1 Physical Medicine device with product code JFC cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K881284 · Nathaniel Gould Diagnostics, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1988
Decision
118d
Days
Class 1
Risk

K881284 is an FDA 510(k) clearance for the COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE. Classified as System, Pressure Measurement, Intermittent (product code JFC), Class I - General Controls.

Submitted by Nathaniel Gould Diagnostics, Inc. (Wallingford, US). The FDA issued a Cleared decision on July 21, 1988 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.1600 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Nathaniel Gould Diagnostics, Inc. devices

FDA 510(k) Submission Details - K881284

510(k) Number K881284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1988
Decision Date July 21, 1988
Days to Decision 118 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 115d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

JFC Device Classification - Class 1, General Controls

Product Code JFC System, Pressure Measurement, Intermittent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.1600
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.